In-vivo biological standardization of Dermatophagoides, Betulaceae and Graminaceae extracts for the determination of the biological activity in HEP units - BIGRADE-IHR -12

OFARMA0 个研究点开始时间: 2012年10月30日最近更新: 2013年5月20日

试验速览

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•1. subjects of both sexes, of any ethnicity, aged between 18 and 50 years (median between 20 and 30 years) with a documented history of at least two years of related allergopatia respiratory exposure to at least one of the allergens tested (Dermatophagoides, Betulaceae and Graminaceae) and who lives in areas where the presence of such allergens represents a significant problem, which is presented in a row; 2. prick-test positive with average diameter (half-sum of the larger diameter and diameter perpendicular to it) of the wheal procured from an extract already standardized, and available commercially, the allergen to be tested = 3 mm, average diameter of the wheal procured by histamine dihydrochloride 1 mg / ml (H1)> 4 mm and a mean diameter of the wheal procured from the negative control (N) <3 mm; 3. intact skin in places of execution of the test; 4. informed consent signed and dated
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. simultaneous participation in other clinical trials or studies completed less than one month prior to enrollment; 2. previous immunotherapy in the last 5 years with a preparation of allergen known to interfere with the allergens to be tested; 3. immunotherapy in progress; 4. individuals with any relationship or dependence by the sponsor and / or investigator; 5. no pregnant or breast feeding patients; 6. immunodeficiency (eg induced by immunosuppressive drugs); 7. atopic dermatitis; 8. dermographism, 9. hives; 10. neurological and infectious diseases that can produce cutaneous anergy; 11. Abuse of alcohol or drugs; 12. taking medications that may interfere with skin reactivity; 13. treatment with tricyclic antidepressants or tetracyclic, phenothiazines, ß-blockers, dopamine, clonidine, corticosteroids (> 10 mg / day of prednisone); 14. should be suspended any oral antihistamines and topical corticosteroids for at least 7 days; 15. exposure of the execution venues to test UV rays, artificial or natural, for therapeutic or aesthetic within 4 weeks.

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